Bio Pharma Dive
JULY 18, 2022
Second quarter reports could bring questions on a reportedly forthcoming $40 billion takeover, GSK’s new slimmed-down look and market uptake for expected blockbusters-to-be from Lilly and Bristol Myers.
Pharmaceutical Technology
JULY 18, 2022
Quoin Pharmaceuticals and Endo International subsidiary Endo Ventures have signed a licence and distribution agreement and a supply agreement to develop, register, supply, market and distribute the former’s QRX003 exclusively in Canada. A lead product of Quoin, QRX003 is a topical lotion intended to treat Netherton Syndrome. As per the terms of the license and distribution deal, Endo holds the exclusive right, which was also sublicensed to the affiliate of the company, Paladin Labs, to market th
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Bio Pharma Dive
JULY 18, 2022
Baisong Mei, a veteran of Sanofi and Biogen, comes to Editas half a year after the gene editing company fired his predecessor and one month after new CEO Gilmore O'Neill started on the job.
Pharmaceutical Technology
JULY 18, 2022
GlaxoSmithKline (GSK) has signed an agreement with the Government of Canada for pandemic and seasonal influenza vaccines to aid in protecting adults and children in the country. Spanning to March 2026, the four-year agreement comprises the delivery of nearly 80 million doses of adjuvanted pandemic influenza vaccine, Arepanrix, and at least four million doses of seasonal influenza vaccine, Flulaval Tetra, each year.
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
Bio Pharma Dive
JULY 18, 2022
The food giant will pay French company Enterome about $40 million to join in the development of an inflammatory bowel disease drug as well as other food allergy treatments.
Pharmaceutical Technology
JULY 18, 2022
The European Commission (EC) has granted conditional marketing authorization (CMA) for Calliditas Therapeutics’ Kinpeygo to treat primary immunoglobulin A (IgA) nephropathy (IgAN) in adults. The treatment is indicated for IgAN patients at risk of quick disease progression risk with a urine protein-to-creatinine ratio (UPCR) ?1.5g/gram. . An orphan medicinal product, Kinpeygo is the first and only therapy to receive approval for IgAN.
Clinical Research Informer brings together the best content for clinical researchers from the widest variety of industry thought leaders.
Pharmaceutical Technology
JULY 18, 2022
Bronchiectasis is defined by the permanent and abnormal damage to the bronchi, causing dilation and scarring, and usually occurs in the context of chronic airway infection and inflammation, often with thick and difficult-to-clear mucus. Bronchiectasis occurs across age groups but is most prevalent in adults and more common in females. Symptoms vary from excessive coughing, chest discomfort, and even weight loss, exacerbating other symptoms such as breathlessness.
Rethinking Clinical Trials
JULY 18, 2022
(From left) Dr. Edward Melnick, Co-PI of EMBED, and Dr. Corita Grudzen, PI of PRIM-ER. Investigators planning emergency department (ED)–based pragmatic clinical trials (PCTs) face multiple decisions during the planning phase to ensure robust and meaningful study findings in this unique setting; however, there is no guide for planning and conducting these studies.
Pharmaceutical Technology
JULY 18, 2022
The proportion of pharmaceutical companies hiring for data analytics related positions rose in June 2022 compared with the equivalent month last year, with 70.1% of the companies included in our analysis recruiting for at least one such position. This latest figure was higher than the 65% of companies who were hiring for data analytics related jobs a year ago and an increase compared to the figure of 67.8% in May 2022.
STAT News
JULY 18, 2022
Patients with vitiligo will now have access to the first ever at-home therapy for skin repigmentation approved by the Food and Drug Administration. The FDA announced the approval of Incyte’s ruxolitinib cream on Monday based on data collected from two duplicate Phase 3 clinical trials that found 30% of patients using the cream regained 75% or more skin repigmentation on the face and roughly 20% of patients regained at least 50% or more repigmentation on their body after 24 weeks.
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
NPR Health - Shots
JULY 18, 2022
How Sotiris Missailidis, head of R&D in Brazil's vaccine agency, used the COVID crisis to push through a game-changing effort for middle-income countries to invent their own mRNA vaccine.
STAT News
JULY 18, 2022
It pays to be in the lab. It pays way less to be at the patient’s bedside. People who work at biotechs, life sciences firms, and pharmaceutical companies pull in the largest salaries of anyone in health care — usually more than $100,000 per year, and frequently above $250,000, according to a STAT analysis of the median pay for employees at more than 200 publicly traded health care companies.
pharmaphorum
JULY 18, 2022
GSK’s consumer health spinout Haleon started trading on the London Stock Exchange this morning, making its debut with a price of 330 pence and a market valuation of around £31 billion ($37 billion). The new company – which has achieved the largest London listing in a decade – has annual sales of around £10 billion from brands like Sensodyne toothpaste, Voltaren and Panadol painkillers, and Centrum multivitamins, making it the second-largest consumer health company in the world.
STAT News
JULY 18, 2022
The pandemic brought a windfall for private health tech startups and fueled a rush to the public markets. And in turn, leaders at some of the industry’s top companies saw their take-home pay skyrocket. It’s difficult to draw broad conclusions about executive compensation in health tech — or how it stacks up to other sectors — because the industry itself is so loosely defined.
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
NPR Health - Shots
JULY 18, 2022
Cycling is especially good for people with long-running knee problems or health issues. I've been able to do everything I've wanted to, but a clamor of what-ifs were often in the back of my mind.
STAT News
JULY 18, 2022
Health care’s top executives sat comfortably atop their perch during the second year of the pandemic, cushioned more than ever by the rising fortunes of their stock ownership. The CEOs of approximately 300 health care companies collectively took home more than $4.5 billion in 2021, according to a STAT analysis of hundreds of financial filings.
NPR Health - Shots
JULY 18, 2022
As the U.S. and Europe spearhead COVID vaccines, other regions are left struggling to gain access. But now scientists from Latin America and Africa are collaborating on mRNA technology.
BioSpace
JULY 18, 2022
There are myriad misconceptions about prescription stimulants for ADHD. But buried within the array of opinions, as with many hot-button topics, are small nuggets of truth.
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
STAT News
JULY 18, 2022
A contract research organization reached a final settlement with the U.S. government to transfer about 4,000 beagles from a facility in which federal authorities had found the dogs didn’t get sufficient veterinary care or food and were living in unsanitary conditions. As part of the deal, Envigo signed a consent decree resolving a civil investigation into a breeding and testing facility in Cumberland, Va., where U.S.
XTalks
JULY 18, 2022
PepsiCo North America is set to invest in the expansion of its Denver, Colorado facility, making it the company’s largest US manufacturing plant to date. Colorado beat three other states to become the site of the massive facility, the company said in a press release last Wednesday. PepsiCo North America acquired roughly 152 acres of land for the planned 1.2 million square foot manufacturing facility.
STAT News
JULY 18, 2022
Health insurers and providers often argue over payments at the negotiating table, but in the boardroom, top executives on each side continue to reap some of the largest pay of anyone in the industry. CEOs at the country’s largest health insurers had a historically lucrative 2021. Median CEO pay among 11 insurers and benefits companies sat at $30 million, the highest of any sector.
BioSpace
JULY 18, 2022
Cancer research facilities are leading the way with methods that will lead to better detection of cancer metastasis, better understanding of cancer cell physiology and greater patient response.
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
STAT News
JULY 18, 2022
Two members of an expert panel that recommended the Food and Drug Administration approve a fish-oil-based heart drug, Vascepa, said recently released data would have led them to reconsider their votes. The concern stems from the suggestion that a substantial benefit the drug showed in a large clinical trial might have been in part due to harm caused by the placebo it was compared to in the study.
BioSpace
JULY 18, 2022
As the BA.4/BA.5 Omicron subvariants spread, researchers continue to develop COVID-19 therapies and approaches for preventing or treating the disease. For that and more, continue reading.
STAT News
JULY 18, 2022
This past June, UnitedHealth Group’s top two executives, Andrew Witty and John Rex, told a crowd at an investor conference that Medicare Advantage — the booming government program that outsources Medicare coverage to health insurance companies — saves the federal government money. But Witty’s and Rex’s claims don’t hold water.
pharmaphorum
JULY 18, 2022
As you know, clinical trials can be complex. Industry standards are now required for clinical trial submission. This means even more associated costs, resources, time, and effort. The Formedix clinical metadata repository ( MDR ) can help! So what can it do for you? In a nutshell, it can help you: How is this possible? Take studies and standards for example.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
STAT News
JULY 18, 2022
When it comes to executive compensation in the biotech and pharma sectors, it pays to be CEO of Regeneron Pharmaceuticals. The company’s chief executive, Len Schleifer, took home $453 million in 2021, more than any other executive in the sector, according to a STAT analysis. That amount represents just less than the entire combined compensation — $478 million — of the next nine highest-paid biotech and pharma CEOs.
BioSpace
JULY 18, 2022
Sanofi has terminated a development agreement with Regulus in Alport syndrome, while Merck reaches the point of futility in a Phase III colorectal cancer trial.
STAT News
JULY 18, 2022
This week, an under-the-radar U.S. government advisory group called the National Committee on Vital and Health Statistics (NCVHS) can vastly improve medical device safety. The NCVHS, which was founded in 1949 , is responsible for developing recommendations and common standards for organizing information and data across the U.S. health care system. This charge includes oversight of the claims forms that facilitate all billing and insurance-related activities.
BioSpace
JULY 18, 2022
The buyout comes on the heels of promising Phase I/II results from GTX-102, an antisense oligonucleotide candidate being developed to treat Angelman syndrome.
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The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.
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